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NCT00948051 Clinical Trial

Effects of follow-on Formula Enriched on Short-chain Fructooligosaccharides (scFOS) on Immune Response in Healthy Infants

Infant Clinical Trial

Official title:
A Placebo-controlled, Double-blind Randomized Study to Evaluate the Efficacy of a follow-on Milk Formula Supplemented With Fructo-oligosaccharides on Immune Response in Healthy Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00948051
Other study ID # FOS_FOF08
Secondary ID
Status Completed
Phase N/A
First received July 27, 2009
Last updated April 12, 2011
Start date March 2009
Est. completion date December 2010

Study information
Verified date April 2011
Source Syral
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial Summary

In this study the investigators hypothesized that the chronic intake of fructo-oligosaccharides would increase fecal immunoglobulin A (IgA) specific to poliovirus vaccination and bifidobacteria in infants.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 4 Months to 5 Months
Eligibility Inclusion Criteria:

- infants aged of 4 months at randomization

- not breast-fed infants

Exclusion Criteria:

- infants suffering from a chronic or severe disease susceptible to interfere with one of the evaluation criteria

- infants suffering from a disease associated with gastro-intestinal disorder

- infants who have taken antibiotic during the 2 months preceding randomization

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Follow-on formula supplemented with fructo-oligosaccharides
Follow-on formula supplemented with fructo-oligosaccharides
• Follow-on formula enriched with placebo (maltodextrins)
Follow-on formula enriched with placebo (maltodextrins)

Locations
Country Name City State
Spain Dr Tormo Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Syral

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the impact of the intake of a follow-on milk formula supplemented with FOS in increasing infant's response to vaccination 1 month No
Secondary To evaluate the impact of the intake of a follow-on milk formula supplemented with FOS in increasing infant's faecal bifidobacteria concentration 1 month No
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